Duns Number:009900424
Device Description: 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)
Catalog Number
S475
Brand Name
20/20™
Version/Model Number
S475
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EAX
Product Code Name
Mirror, Mouth
Public Device Record Key
98cda766-62c2-41a8-980c-2a005b51b32c
Public Version Date
September 09, 2019
Public Version Number
1
DI Record Publish Date
August 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |